Purpose: To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental).
Materials and methods: A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician.
Results: In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone.
Conclusions: No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs. Conflict-of-interest statement: This research project was originally funded by Keystone Italia, Dental spa (Verona, Italy), the manufacturer of the implants evaluated in this investigation. However, when Keystone Italia received the data of the present manuscript, they refused to honour the financial agreement for the present publication. Therefore, no further follow-ups of this trial will be considered. A legal action was initiated against Keystone Italia. The data belonged to the authors and by no means was the manufacturer allowed to interfere with the conduct of the trial or the publication of the results.